9/03/2019

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Male breast cancer is rare, but nonetheless as deadly as for women when at the same stage of progression. Men have been traditionally excluded from breast cancer clinical trials, so any treatment for them has been developed with data from women subjects. This results in fewer FDA approved treatment options for men with breast cancer.

08/06/2019

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The Food and Drug Administration (FDA) announced the availability of the draft guidance “E8(R1) General Considerations for Clinical Studies” for public comment. The purpose of the draft guidance is to increase flexibility of clinical trials while improving the quality of clinical trial data presented to regulatory authorities. The draft guidance originates from the International Council for Harmonisation’s (ICH) E8 draft revision. The revision is part of ICH’s Good Clinical Practice (GCP) Renovation initiative, which outlines plans to revise ICH E8 and further revise ICH E6.

7/23/2019

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What does ‘T’ stand for?

Everyone talks about learning from when things go wrong. People say it's the best way to learn. But it's not always easy. The DIGR-ACT® solution gives you a way. By taking you through the issue to the root cause, actions and then making sure the actions work, you have learned from the issue. Maybe your learning can be transferred to others? Perhaps the same problem happens to other people too?

7/09/2019

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What does ‘C’ stand for?

Do you care whether the actions you took to try to stop an issue from recurring were completed? Does it matter if they actually worked? Of course! Deciding on actions is only part way to fixing a problem. We need to complete the actions and make sure they were effective. That's why there is the ‘C’ step in the DIGR-ACT® solution, where C stands for ‘Check’.

6/25/2019

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The Food and Drug Administration (FDA) released a draft guidance “Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs”. It is the position of the FDA to enroll subjects who are the target audience for the investigational product once approved. Certain populations are underrepresented in clinical trials, even though they are part of the target audience. The draft guidance outlines methods the sponsor can use to support more diverse enrollment that more accurately reflects the target population, in accordance with requirements in the FDA Reauthorization Act of 2017 (FDARA).

6/20/2019

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What does ‘A’ stand for?

Don't waste time on root cause analysis, at least not if you won’t use the results! Proper root cause analysis takes effort and resources, and you need to use the output to determine actions to try to stop the issue recurring. This is the ‘A’ step of the DIGR-ACT® solution. Having dug into the issue, you now need to ‘Act’ on what you found.

6/11/2019

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Clinical trials have become increasingly complex since the ICH E8 guideline on “General Considerations for Clinical Trials” was finalized in 1997. The draft revision is in Step 2b and available for public comment, and there are some interesting changes to note. Specifically, there is a greater emphasis on patient centricity, design of trials with quality in mind, and risk management. The overlying theme is fit-for-purpose quality as an essential consideration for study design. The revision is part of the Good Clinical Practice (GCP) Renovation initiative. Previously, the ICH E6 GCP R2 addendum was finalized in 2016.